Abstract
BackgroundThe Institute of Medicine (IOM) reported that chronic pain affects about 100 million U.S. adults, with chronic low back pain (CLBP) cited as the most prevalent type. Pain catastrophizing is a psychological construct shown to predict the development and trajectory of chronic pain and patient response to pain treatments. While effective treatment for pain catastrophizing typically includes eight-session groups of cognitive behavioral therapy (CBT), a single-session targeted treatment class yielded promising results which, if replicated and extended, could prove to efficiently and cost-effectively reduce pain catastrophizing. In this trial, we seek to determine the comparative efficacy of this novel single-session pain catastrophizing class to an eight-session course of pain CBT and a single-session back pain health education class. We will also explore the psychosocial mechanisms and outcomes of pain catastrophizing treatment.MethodsIn this trial we will randomize 231 individuals with CLBP to one of three treatment arms: (1) pain-CBT (eight weekly 2-h group sessions with home exercises and readings); (2) a single 2-h pain catastrophizing class; or (3) a single 2-h back pain health education class (active control). For the primary outcome of pain catastrophizing, the trial is designed as a non-inferiority test between pain-CBT and the single-session pain catastrophizing class, and as a superiority test between the single-session pain catastrophizing class and the health education class. Team researchers masked to treatment assignment will assess outcomes up to six months post treatment.DiscussionIf the single-session targeted pain catastrophizing class is found to be an effective treatment for patients with CLBP, this low cost and low burden treatment could dismantle many of the current barriers and burdens of effective pain care. Further, elucidation of the mechanisms of pain catastrophizing treatments will facilitate future research on the topic as well as further development and refinement of treatments.Trial registrationClinicalTrials.gov, NCT03167086. Registered on 22 May 2017.
Highlights
The Institute of Medicine (IOM) reported that chronic pain affects about 100 million U.S adults, with chronic low back pain (CLBP) cited as the most prevalent type
We achieve 90% power to reject the null hypothesis of equal means when the population mean difference is 5 (63% of that seen in the pain-cognitive behavioral therapy (CBT) literature; 45% of that seen in Preliminary Study 1) and 80% power to reject the null when the population mean difference is 4.3 (54% of that seen in the pain-CBT literature; 40% of that seen in Preliminary Study 1), with standard deviation (SD) for both groups of 8, α = 0.05, using a two-sided, two-sample equal-variance t-test
In this trial, we will seek to determine whether a singlesession targeted pain catastrophizing (PC) class is an effective treatment option for persons with chronic back pain
Summary
In this trial we will randomize 231 individuals with CLBP to one of three treatment arms: (1) pain-CBT (eight weekly 2-h group sessions with home exercises and readings); (2) a single 2-h pain catastrophizing class; or (3) a single 2-h back pain health education class (active control). For the primary outcome of pain catastrophizing, the trial is designed as a non-inferiority test between pain-CBT and the single-session pain catastrophizing class, and as a superiority test between the single-session pain catastrophizing class and the health education class. Team researchers masked to treatment assignment will assess outcomes up to six months post treatment
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